FDA ANDA 213118 Review Report for Carboprost Tromethamine Injection

FDA ANDA 213118 Review Report for Carboprost Tromethamine Injection

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Original Request: 1. The US FDA reviewing report (including ANDA reviewing report and PAS reviewing report) for ANDA 213118 (MAH:Sunny Pharmtech Inc.) Carboprost Tromethamine Injection, USP 250 mcg/mL, including the Summary Review, Chemistry Review, Pharmacology Review, etc.
Tags: Pharma, ANDA, 2024
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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